Why it was recalled
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Product description
2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Lot numbers, UPCs & expiration codes
Service Code 2K9226 , Lot Number 160450145M , Exp. Date 5/9/2016 ; Service Code 2K9226 , Lot Number 160530166M , Exp. Date 5/17/2016 ; Service Code 2K9226 , Lot Number 160560080M , Exp. Date 5/19/2016 ; Service Code 2K9226 , Lot Number 160670164M , Exp. Date 5/31/2016 ; Service Code 2K9226 , Lot Number 160730130M , Exp. Date 6/6/2016 ; Service Code 2K9226 , Lot Number 160770032M , Exp. Date 6/10/2016 ; Service Code 2K9226 , Lot Number 160810035M , Exp. Date 6/13/2016 ; Service Code 2K9226 , Lot Number 160820135M , Exp. Date 6/15/2016 ; Service Code 2K9226 , Lot Number 160870152M , Exp. Date 6/20/2016 ; Service Code 2K9226 , Lot Number 160890036M , Exp. Date 6/22/2016 ; Service Code 2K9226 , Lot Number 160950040M , Exp. Date 6/27/2016 ; Service Code 2K9294 , Lot Number 160400210M , Exp. Date 5/10/2016 ; Service Code 2K9294 , Lot Number 160700164M , Exp. Date 6/9/2016 ;
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1392-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 5, 2016
- FDA report date
- Jul 27, 2016
- Quantity
- 950 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-1392-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 74057
- Address
- 150 N Field Dr Ste 350
- Code information
- Service Code 2K9226 , Lot Number 160450145M , Exp. Date 5/9/2016 ; Service Code 2K9226 , Lot Number 160530166M , Exp. Date 5/17/2016 ; Service Code 2K9226 , Lot Number 160560080M , Exp. Date 5/19/2016 ; Service Code 2K9226 , Lot Number 160670164M , Exp. Date 5/31/2016 ; Service Code 2K9226 , Lot Number 160730130M , Exp. Date 6/6/2016 ; Service Code 2K9226 , Lot Number 160770032M , Exp. Date 6/10/2016 ; Service Code 2K9226 , Lot Number 160810035M , Exp. Date 6/13/2016 ; Service Code 2K9226 , Lot Number 160820135M , Exp. Date 6/15/2016 ; Service Code 2K9226 , Lot Number 160870152M , Exp. Date 6/20/2016 ; Service Code 2K9226 , Lot Number 160890036M , Exp. Date 6/22/2016 ; Service Code 2K9226 , Lot Number 160950040M , Exp. Date 6/27/2016 ; Service Code 2K9294 , Lot Number 160400210M , Exp. Date 5/10/2016 ; Service Code 2K9294 , Lot Number 160700164M , Exp. Date 6/9/2016 ;
- Postal code
- 60045-2506
- Report date
- Jul 27, 2016
- Product type
- Drugs
- Recall number
- D-1392-2016
- Classification
- Class II
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 950 bags
- Termination date
- Mar 6, 2018
- Reason for recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Distribution pattern
- Nationwide
- Recall initiation date
- May 5, 2016
- Initial firm notification
- Center classification date
- Jul 16, 2016